The company intends to charge $89,000 a year for a drug which has been available in Canada, the United Kingdom and Europe for decades for $1,000-$1,600 a year, according to the Wall Street Journal. It is said that the condition occurs in about one in every 3,600 male infants across the globe.
It commonly implies the medication will be secure by insurance, and the evidence that is utilized to support the approval may induce doctors to use the medications. The drug also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. Image credit: USA Today.$89,000 a year to treat the disease in the U.S.
Marketed by Illinois' Marathon Pharmaceuticals, Emflaza is available as tablets and oral suspension.
Muscular dystrophy treatment from Marathon Pharmaceuticals LLC will cost $89,000 per year for patients in the United States. However, the drug was never approved by the FDA as no companies thought it profitable enough to jump through the regulatory hoops necessary to sell it in the U.S. Patients have been importing the drug since the 90s, but now they will have to pay 50 to 70 times what they used to pay if they want to get it in the U.S. Sarepta's drug treats a subset of DMD patients representing about 13 percent of the total. In its response last week to the FDA's approval, the Illinois-based company said it was committed to ensuring that USA patients with prescriptions have access to the drug and that the company would provide the most robust patient support programs "allowed by law to qualifying patients". This is the ninth rare pediatric disease priority review voucher issued by the FDA since the program began. It improves muscle strength. Their ages ranged between 5 and 15 at the beginning of the trial. Twelve weeks into the study, patients, who were taking deflazacort, showed marked improvements in muscle strength compared to those were taking a placebo. An overall stability in average muscle strength was maintained through the end of study at week 52 in the deflazacort-treated patients. The Lindenhurst mother wonders whether Liam, who's now in a wheelchair, would have walked longer if he had access to deflazacort earlier.
The most common adverse effects with Emflaza included Cushingoid appearance, weight gain, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, and central obesity. Other side effects include mood swings, elevated blood pressure, infection and serious skinj rashes. It can also lead to a reduction in the density of the bones.
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